(185 days)
Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.
The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.
This looks like a submission record to the FDA for a 510(k) premarket notification for a medical device. Based on the provided text, there is no information about specific acceptance criteria, a study proving device performance against those criteria, or the details typically associated with clinical performance studies (sample sizes, ground truth establishment, expert qualifications, etc.).
The document {0} states "Performance data is presented in the 510(k) submission," but this specific summary does not contain that data or the acceptance criteria. The subsequent pages {1}, {2}, and {3} are an FDA response letter confirming substantial equivalence to a predicate device and the "Indications For Use" statement.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets those criteria, as these details are not present in the provided text.
{0}------------------------------------------------
K98 3105
9.0 Summary of Safety and Effectiveness
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA, 1990.
| Submitted by: | CCS Inc.5 Oxford Street West, London, Ontario, Canada. N6H 1R1Phone 519-672-1190 Fax 519-672-8557 | |
|---|---|---|
| Prepared by: | CATCO:Competitive Advantage Tools Company2288 Yorktown Circle, Mississauga, Ontario, Canada. L5M 5Y2Phone 905-819-9425 Fax 905-819-9562Steve Long, President | |
| Date: | August 31, 1998 | |
| Trade Name: | CCS Computer Controlled SyringeCCS Cartridge Holder | (Model CCS-100)(Model CCS-100-01) |
| Classification: | Class II. 21 CFR 872.6770 | |
| Predicate Device: | The Wand (K961648) | |
| Device Description: | The CCS computer controlled syringe is a programmable electronicdevice that allows the injection of local anesthetics commerciallyavailable and packaged in cartridge form. The device consists of aprogrammable control unit, and a handpiece with switches that actuatethe function of the device as programmed. Single use, replacementcartridge holders are available to facilitate universal injection technique. | |
| Intended Use: | Indicated for the injection of local anesthetics for infiltration and nerveblock anesthesia administered prior to, or in conjunction with, dentalprocedures. | |
| Sterility: | The described devices are non-sterile. | |
| Performance Data: | Performance data is presented in the 510(k) submission. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and a human profile in the negative space below the wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 1999
Computer Controlled Syringe, Incorporated C/O Mr. Steve Long President CATCO:Competitive Advantage Tools Company 2288 Yorktown Circle Mississauga, Ontario, CANADA L5M5Y2
Re : K983105 CCS; Computer Controlled Syringe, Model Trade Name: #CCS-100, CCS; Cartridge Holder, Model #CCS-100-01 Regulatory Class: II Product Code: EJI February 18, 1999 Dated: February 22, 1999 Received:
Dear Mr. Long:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{2}------------------------------------------------
Page 2 - Mr. Long
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
. Page 1 of 1
510(k) Number (if known): K983105
Device Name: CCS
Indications For Use:
The CCS Computer Controlled Syringe is an electronic programmable device indicated The OCS Computer Controller of the infiltration and nerve block anesthesia for the injocular of lead an conjunction with, dental procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . 3100
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.